CONSENSUS AND RECOMMENDATION OF THE L1 GLOBAL HARMONIZATION TEAM ON RUN ACCEPTANCE FOR LARGE MOLECULE BIOANALYSIS TO SUPPORT PHARMACOKINETICS

The L1 Global Harmonization Team on run acceptance, specifically for large molecule bioanalysis in support of pharmacokinetics, focused on standard curve calibrators and quality controls for use in both validation and study sample analysis, including their preparation and acceptance criteria. The team also considered curve editing and the concept of Total Error.